BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTML-CLEAR ALIGNER-DUAL ARCH

    MDR report key: 6110695 · Received November 17, 2016

    Report

    Report Number
    1036212-2016-00013
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    October 18, 2016
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K132145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD BEEN WEARING MTM ALIGNERS AND IT APPEARS AS THOUGH TOOTH #9 BECAME INTRUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760050 MTML-CLEAR ALIGNER-DUAL ARCH ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 14940-R1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention